As a member of the European Union, Italy has been implementing European directives concerning genetically modified organisms (GMOs) over the last two decades, but at a rather reluctant pace. In fact, as reflected by GMO legislation in Italy, Italian public opinion has shifted from a decidedly general opposition to the introduction of GMOs into a more recent open acceptance of them. Italy’s political and administrative structure relies on the powers of the central government and the governments of its twenty regions, which enjoy certain autonomy in the regulation of agriculture and crops, and in experimentation with GMOs. As a consequence, some regions have enacted slightly more permissive regimes than others. In addition, the Italian Constitutional Court has ruled that the national government is constrained from encroaching on the power of regional governments to establish their own regimes on GMOs. This factor, in conjunction with the more permissive regulations to which Italy is bound at the European level, creates a scenario where the decentralized and spontaneous growth of GMOs in agriculture will probably increase in the near future.

I. Introduction

Early regulations concerning genetically modified organisms (GMOs) in Italy were aimed at deterring their development in the country. However, the flow of European regulations from the late 1990s onward changed the legal framework for regulating GMOs. Pursuant to European Union (EU) Directive Nos. 219 and 220 of 1990, and 259 of 1997, Italy cannot limit the importation of GMOs, which are already approved at the European level. In 2000, Italy for the first time enacted legislation to ban the use of certain GMOs used in foods for human consumption (see discussion, Part III(C), below). Two years later legislation imposed a moratorium on the mixture of GMO and non-GMO products. Finally, several pieces of legislation enacted since early 2003 have sought to more strictly regulate GMO experimentation, use, mixtures, and release into the environment, particularly concerning GMOs used for food crops. Thus, at this point, GMO cultivation is currently permitted in Italy, but subject to stringent regulations concerning the assessment of its impacts on human and animal health, and the environment.

II. Public and Scholarly Opinion

GMOs have received a mixed reception by the general public in Italy. For some observers, the incorporation of new technologies altering the genetic code of plants and animals has represented a success in the quest for maximization of food alternatives.[1] For others, the introduction of GMOs in Italy has generated serious concerns related to food safety and consumer protection. For instance, the introduction of proteins and genes into GMOs that have not previously been consumed by animals or humans (e.g.,scorpion genes in potatoes or bacteria in maize), and their subsequent impact on the food chain is a very controversial matter.[2] Another common objection to GMOs arises over the dangers of GMOs escaping from their confined environments and mixing with populations living under natural conditions.[3]

Overall, despite the European GMO regulations, the general public has strongly opposed the introduction of GMOs into Italy, and this opposition has had an impact on Italian legislation since at least 2000.[4]

Only recently, on July 12, 2013, the Italian government banned the cultivation of Monsanto Corn 810 (Mon810), as the first of a series of measures designed to define a new more restrictive framework for the cultivation of GMOs in Italy.[5] However, fresh opinion polls indicate that the Italian public is now adopting a slightly more pro-GMO stance.[6]

III. Structure of Pertinent Legislation

A. Definition of “GMO”

In Italy, GMOs (Organismi Geneticamente Modificati) are defined as “organisms whose genetic material has been altered in a way that does not occur naturally for fertilization and/or natural recombination. GMOs can be plants, animals, or microorganisms, such as bacteria, parasites and fungi.”[7] GMOs from both plants and animals are used in food, agriculture, animal husbandry, and medicine.[8] Nonetheless, the scientific community uses the terminology “GMO” mainly to
describe plants whose hereditary patrimony has been altered by receiving genes, thereby transforming their cells or tissues.[9]

Specifically, Legislative Decree (L.D.) No. 224 of 2003 defines a GMO as “an organism, different from a human being, whose genetic material has been altered in a way that does not occur in nature through coupling or intersection or natural recombination.”[10]

B. EU Law

The complexity of the ethical and economic questions involved in the production of GMOs has caused the EU to regulate this field through Directive Nos. 90/219, 259/97, and 2001/18, which replaced Directive 90/220[11] As a consequence of these directives, Italy may neither limit the importation of GMOs authorized at the European level nor prohibit their cultivation for reasons other than those scientifically supported.

European GMO legislation, which rests on the precautionary principle,[12] comprises the following instruments:

Regulation (EC) No. 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed

Regulation (EC) No. 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labeling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC

Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 (amended by Regulation (EC) No. 1830/2003) on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (which had required producers to demonstrate to authorities that a new product abided by certain security standards)

Commission Recommendation 2003/556/EC of 23 July 2003 on guidelines for the development of national strategies and best practices to ensure the coexistence of genetically modified crops with conventional and organic farming[13]

C. Domestic Legislation

The first attempt to block the entry of GMOs into Italy took place in 2000 with the issuance by the President of the Council of Ministers of the Decreto Amato,[14] which banned the use of foods derived from GMO Corn 4. This provision was adopted pursuant to a safeguard clause included in European Regulation 258/97, which had authorized the use of GMO Corn 4 at the European level. The Decreto Amato was repealed, however, by a court in 2004 for lack of evidence that GMO Corn 4 caused a health hazard. In consequence, this GMO may now be freely cultivated and used in Italy.

The debate over transgenic products continued in Italy when in 2000 a group of more than 1,500 Italian scientists—including Nobel Prize recipients—signed a letter opposing a total ban on scientific research on GMOs.[15] The Decreto Alemanno, adopted in 2002, contained rules for the coexistence of GMO, conventional, and organic agriculture. This instrument established a moratorium on mixing GMO and conventional seeds, with severe penalties for violators, and suspended the GMO experimentation that the government was conducting in accordance with regulations of the Ministry of Agricultural, Food, and Forestry Policies.[16]

As already stated, Italy had for many years adopted a zero-tolerance policy concerning GMO seeds. In fact, in 2003, there was an incident in the Piedmont Region where the local government ordered the destruction of areas destined for GMO-crop cultivation based on the fact that the ratio of GMO seeds to conventional seeds exceeded the maximum ratio allowed by European and Italian regulations. This decision was not echoed at the national level or in other regions of the country, however.

In addition, European Directive 2001/18/EC was implemented in Italy by Legislative Decree No. 224 of 2003.[17] Along with the existing required standards and evaluations for conducting experiments with GMOs, this Decree mandated the prior assessment of, among other activities,

(a) the abandonment or replacement of crops that, owing to the impact of GMOs, have become no longer appropriate or economically convenient, particularly regarding local varieties;

(b) damage to the image of local products and/or the release area and the costs involved to defend the image;

(c) a change of market patterns caused by products originating in the release area due to the impossibility of purchasing GMO-free products, or other commercial impacts;

(d) modifications of the landscape with negative impacts on agro-tourism activities; and

(e) abandonment or marginalization of the release area caused by the impairment of agricultural practices in the area that have become less profitable owing to GMO impacts.[18]

Decree-Law No. 279 of 2004,[19] which was amended and enacted as legislation by Law No. 5 of 2005,[20] provided for equality between different types of agriculture but imposed on the regions and autonomous provinces a “plan of coexistence” to prevent the commingling of GMO products and non-GMO products. Before its conversion into law in 2005, Decree-Law No. 279 was declared partially unconstitutional with regard to the coexistence of crops and the jurisdiction of the Italian regions (see the analysis of this decision in Part VIII, below). As a consequence, the twenty regions (political-administrative divisions) of the country are now free to determine their own policies concerning the coexistence of GMO and non-GMO agriculture, but to conform with European regulations they may not prohibit GMO crops altogether. Currently, thirteen of the regions have issued provisions imposing de facto restrictions on the cultivation of GMOs in their territories.

In sum, GMO cultivation in Italy is taking place at an experimental level only. At the same time, most of the fodder used on Italian farms is produced from genetically modified soy and corn imported from the United States, Canada, and Latin America.

IV. Restrictions on Research, Production, and Marketing

L.D. No. 224 of 2003 provided that information about GMOs must be made available to the general public on a transparent and continuous basis,[21] with some exceptions related to the confidentiality of the concerned information.[22] L.D. No. 70 of 2005[23] established a three-year moratorium on including GMOs in foods or feeds in a ratio greater than 0.5% of the non-GMO content.[24] In addition, L.D. No. 224 of 2003 mandated that companies authorized to release GMOs engage in post-release monitoring and research activities,[25] and created a digital public registry to inventory the localization of authorized GMOs released around the country.[26] Finally, L.D. No. 224 of 2003 established a procedure for the exchange of information on GMOs with the European Commission and other EU member states.[27]

These statutory authorities are complemented by Presidential Decree No. 433 of 2001,[28] which contains provisions related to data protection relevant for GMO cultivation.[29]

V. Restrictions on Releasing Organisms into the Environment

L.D. No. 124 of June 25, 2010[30] (L.D. No. 124) sets forth mandatory criteria concerning the release of GMOs into the stream of commerce; that is, notification, environmental impact assessment, and public consultation requirements.[31] L.D. No. 124 charges the Ministry of Agricultural, Food, and Forestry Policies with the main responsibility for determining national policies on agriculture, food security, and forests.[32] L.D. No. 124 also permits the release of materials into the food chain that will cause the multiplication of fruit plants designed to contribute to genetic diversity.[33] In addition, L.D. No. 124 provides that labeling for GM fruit plants must clearly indicate that the variety has been genetically modified and must specify the organism that has been genetically modified.[34] Moreover, L.D. No. 124, which does not apply to the transportation of GMOs over railroads, streets, internal navigable waters, or by sea or air,[35] creates an interministerial commission charged with reviewing GMO authorizations.[36]

Complementing L.D. No. 124, Presidential Decree No. 433 of 2001 provides that no additives may be released without the previous appropriate authorizations,[37] and that such authorizations must include the pertinent permits issued by EU authorities.[38]

VI. Restrictions on GMOs in Foodstuffs

L.D. No. 224 of 2003,[39] (L.D. No. 224) which does not apply to GM substances and medicinal preparations for human use, reinforces compliance with labeling and packaging requirements for GMOs that have been authorized for marketing and distribution.[40] L.D. No. 224 authorizes the Ministries of the Environment, of Health, and of Agricultural, Food, and Forestry Policies to limit or temporarily suspend the commercialization of GMOs based on new scientific information concerning risks to humans, animals, or the environment.[41]

Complementing L.D. No. 224, Presidential Decree No. 433 of 2001 includes other norms related to the labeling, packaging, and commercial distribution of GMO additives,[42] and regulates their monitoring and control.[43]

VII. Liability Regime and Criminal Penalties

The civil liability regime for damages arising from GMO-related activities in Italy is that set forth in the Civil Code, and therefore reflects the negligence-based liability structure that applies to torts.[44]

In particular, L.D. No. 224 contains provisions for damage to human health and the environment, environmental remediation and restoration, and compensation for environmental damage. L.D. No. 224 specifically provides that anyone who by an act or omission, in violation of L.D. No. 224, causes damage to water, soil, subsoil, or other environmental resources that leads to a real and present danger of environmental pollution must, at their own expense, implement measures for safety and for the remediation and environmental restoration of the polluted areas.[45]

In turn, L.D. No. 70 of 2005[46] establishes penalties for those who, without the proper government authorizations, commercially distribute a GMO designed for human nutrition or a food that contains or has been produced with GMOs. Those who fail to take the appropriate measures to monitor the performance of the GMO, or who do not inform the authorities about ensuing developments affecting the security of the GMO, are also subject to penalties.[47]

L.D. No. 70 of 2005 also provides additional penalties for those who release GMOs into the market without complying with labeling requirements, or who release food that contains a higher concentration of GMOs than that authorized by law or the authorities.[48] Furthermore, penalties are imposed on those who release GMOs designed as animal food or feed without complying with the Law’s specified authorizations and labeling requirements.[49]

VIII. Judicial Decisions / Prominent Cases

Perhaps the most important judicial decision concerning GMOs in Italy is that issued by the Constitutional Court in 2006[50] on the constitutionality of Decree-Law No. 279 of 2004. The Court partially annulled this Decree-Law based on procedural irregularities in the legislative process that led to its enactment, and considered its powers as an encroachment by the national government on the powers of the regions. Furthermore, the Court held that the executive branch did not hold “consultation and wide debate” prior to adopting the measure as required by the Constitution. In addition, the Court considered arguments concerning the alleged irreversibility of the potential damage posited by the admixture of GMO products and non-GMO products. The effect of this decision was to allow for a decentralization of the national government’s policy-making powers concerning GMOs and an increase in regional power. The practical result has been a lack of uniform national policies concerning GMOs in Italy.